HHS is establishing the Pandemic Influenza Countermeasures Injury Table as authorized by the Public Readiness and Emergency Preparedness Act (PREP Act). Through this final rule, the Secretary of the U.S. Department of Health and Human Services (Secretary) adds regulations for the purpose of creating Covered Countermeasures Injury Tables. The pandemic influenza countermeasures are identified in Secretarial declarations relating to pandemic influenza, including influenza caused by the 2009 H1N1 pandemic influenza virus (hereafter referred to as the 2009 H1N1 virus) and other potential pandemic strains, such as H5N1 avian influenza.

Written comments must be submitted on or before May 30, 2014. Subject to consideration of the comments received, the Secretary intends to publish a final regulation.

42 CFR Part 110

Summary

The Public Readiness and Emergency Preparedness Act (PREP Act) directs the Secretary of Health and Human Services (the Secretary), to establish a Countermeasures Injury Compensation Program (the Program) to provide “timely, uniform, and adequate compensation” to eligible individuals who sustain serious physical injuries or to certain survivors of individuals who die as a direct result of the use or administration of covered countermeasures identified by the Secretary in declarations issued under the PREP Act. The Secretary has delegated authority to administer the Program to the Health Resources and Services Administration (HRSA). Through this regulation, the Secretary proposes a Table for pandemic influenza covered countermeasures identified by the Secretary in several PREP Act declarations. This regulation also includes proposed Table time intervals for the first symptom or manifestation of onset of injury, Table injury definitions, and requirements which define the terms and conditions included on the Table. These are considered part of the proposed Table.